Spectral Medical Inc. (TSX: EDT) has announced that its Tigris trial, a Phase 3 study assessing Polymyxin B Hemoperfusion (PMX) for treating endotoxemia and septic shock, has reached 101 enrolled patients. This randomized controlled trial is designed to evaluate PMX's effectiveness in adults suffering from these critical conditions.
Enrollment Momentum
The Tigris trial has demonstrated robust enrollment throughout 2024, with a record 17 patients enrolled in the first quarter. A total of 20 patients have been enrolled in 2024, reflecting the most robust enrollment rates since the study's inception. With 49 patients remaining to reach full enrollment, Spectral is focused on completing the trial.
To bolster enrollment efforts, Spectral convened an in-person Investigator Meeting on March 12th and 13th in San Diego, alongside the 29th International Conference on Advances in Critical Care Nephrology. The meeting saw participation from principal investigators, clinical research coordinators, representatives from Beaufort (the CRO), and Baxter, Spectral’s strategic partner.
Trial Site Support
The Tigris trial is currently being conducted across 22 sites. Spectral is actively working to open two additional clinical sites. The company's clinical team is dedicated to providing the necessary support and resources to these sites, ensuring efficient patient enrollment.
About PMX and Endotoxic Septic Shock
Spectral's primary focus is gaining U.S. FDA approval for Toraymyxin™ (PMX), a therapeutic hemoperfusion device designed to remove endotoxin from the bloodstream, addressing a key factor in sepsis. PMX is guided by the Endotoxin Activity Assay (EAA™), Spectral's FDA-cleared diagnostic tool for assessing the risk of developing sepsis.
PMX has already been approved for use in Japan and Europe, where it has been used safely and effectively in over 340,000 patients. Spectral obtained exclusive U.S. development and commercial rights for PMX in March 2009 and signed an exclusive distribution agreement for Canada in November 2010. In July 2022, the FDA granted Breakthrough Device Designation to PMX for the treatment of endotoxic septic shock, a severe form of sepsis affecting approximately 330,000 patients in North America annually.
The Tigris trial is designed as a 2:1 randomized trial involving 150 patients, comparing PMX plus standard care against standard care alone, utilizing Bayesian statistics.
